ACTIVE IMMUNIZATION OF PATIENTS WITH HIV-INFECTION - A STUDY OF THE EFFECT OF VAXSYN, A RECOMBINANT HIV ENVELOPE SUBUNIT VACCINE, ON PROGRESSION OF IMMUNODEFICIENCY

Infection with the human immunodeficiency virus (HIV) leads to a progr essive immunodeficiency characterized by decreasing levels of CD4(+) T lymphocytes, VaxSyn, a vaccine based on the recombinant envelope glyc oprotein subunit (rgpl60) of HIV-1(IIIB), was used to immunize HIV-inf ected patients to determine whether its administration was beneficial with respect to slowing disease progression, A 3-year multicenter, ran domized, placebo-controlled, double-blinded, efficacy and safety trial of repeated immunization with VaxSyn was used to evaluate the long-te rm impact on the progression of immunodeficiency, VaxSyn in alum, or a lum alone, was given to 278 HIV-infected asymptomatic individuals with initial CD4 counts of greater than or equal to 500 cells/mm(3), Clini cal findings, the CD4 count, and both virological and immunological pa rameters were followed, No significant differences were observed betwe en the treatment and placebo control groups in rate of CD4 T cell decl ine, time to initiation of antiretroviral therapy, incidence of opport unistic infections, HIV RNA plasma viremia, HIV viral infectivity as m easured by quantitative HIV coculture assay, and death, This study rev ealed no effect on either clinical or laboratory virological parameter s from the administration of VaxSyn.